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Lasmiditan Compared to Placebo in the Acute Treatment of Migraine: (SAMURAI)

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ClinicalTrials.gov Identifier: NCT02439320
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a prospective randomized, double-blind, placebo-controlled study in subjects with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: Lasmiditan 100 mg Drug: Lasmiditan 200 mg Drug: Placebo (matches lasmiditan doses) Phase 3

Detailed Description:
Subjects will be asked to treat a migraine attack with study drug on an outpatient basis. Subjects will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each subject's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study
Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Lasmiditan 100 mg
Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Drug: Lasmiditan 100 mg
Drug: Placebo (matches lasmiditan doses)
Experimental: Lasmiditan 200 mg
Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Drug: Lasmiditan 200 mg
Drug: Placebo (matches lasmiditan doses)
Placebo Comparator: Placebo
Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Drug: Placebo (matches lasmiditan doses)



Primary Outcome Measures :
  1. Proportion of subjects headache pain free at 2 hours post dose [ Time Frame: 2 hours post dose ]
    Defined as moderate or severe headache pain becoming none


Secondary Outcome Measures :
  1. Proportion of subjects who are most bothersome associated symptom (MBS) free at 2 hours post dose [ Time Frame: 2 hours post dose ]
    Defined as the associated symptom present and identified as MBS prior to dosing being absent at 2 hours.


Other Outcome Measures:
  1. Headache relief [ Time Frame: 2 hours post dose ]
    A reduction in headache pain from moderate or severe to mild or none

  2. Use of rescue medication [ Time Frame: 2 hours post dose, 2-24 hours post dose and 48 hours ]
  3. Headache recurrence [ Time Frame: From 2 hours post dose up to 48 hours ]
    The proportion of subjects with headache recurrence (moderate or severe headache at baseline, which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose)

  4. Proportion of patients nausea free, phonophobia free or photophobia free [ Time Frame: 2 hours post dose ]
    Defined as the specified associated symptom being absent at 2 hours post-dose

  5. Safety [ Time Frame: up to 11 weeks ]
    Adverse events

  6. Resource utilization [ Time Frame: 6 months prior to enrolling in study to End of Study visit (within 7 days of treating a single migraine attack) ]
    Use of health care for treatment 6 months prior to enrolling in the study compared to information reported during time on study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to give written informed consent.
  • Patients with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
  • History of disabling migraine for at least 1 year.
  • MIDAS score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3 - 8 migraine attacks per month (< 15 headache days per month).
  • Male or female, aged 18 years or above.
  • Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
  • Able and willing to complete an electronic diary.

Exclusion Criteria:

  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
  • History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the subject at increased risk of seizures.
  • History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
  • History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
  • History of orthostatic hypotension with syncope.
  • Significant renal or hepatic impairment.
  • Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
  • Known Hepatitis B or C or HIV infection.
  • History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.
  • Use of more than 3 doses per month of either opiates or barbiturates.
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439320


  Show 92 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
CoLucid Pharmaceuticals
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02439320     History of Changes
Other Study ID Numbers: 16888
H8H-CD-LAHJ ( Other Identifier: Eli Lilly and Company )
COL MIG-301 ( Other Identifier: CoLucid Pharmaceuticals )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases